Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial looking at oxaliplatin and 5FU for advanced biliary tract cancers (ABC-06)
This trial was done to find out if oxaliplatin and 5FU is useful for people with advanced biliary tract cancer who have already had chemotherapy.
The trial was supported by Cancer Research UK. It was open for people to join between 2014 and 2017. The team published the results in 2021.
More about this trial
Biliary tract cancers include cancer of the:
- bile duct (cholangiocarcinoma)
- area where the pancreatic duct meets the bile duct (ampullary cancer)
Doctors often treat biliary tract cancer that has spread with chemotherapy, such as gemcitabine and cisplatin. But the cancer can start to grow again.
When this trial was done, doctors would treat the symptoms of cancer for people in this situation. This is called active symptom control, or ASC. It includes treatment such as painkillers, antibiotics or steroids. But there was no standard chemotherapy treatment.
Researchers wanted to find out if oxaliplatin and fluorouracil (5FU) could be helpful for people in this situation. You have these drugs with another drug called folinic acid, which helps 5FU work better. This combination is known as FOLFOX.
The main aims of the trial were to find out:
- if FOLFOX could help people with advanced biliary tract cancer
- more about the side effects of FOLFOX for people in this situation
Summary of results
The research team found that FOLFOX may be a useful treatment for people with biliary tract cancer that has got worse after previous chemotherapy.
This trial was for people who had already had chemotherapy. But their cancer continued to grow, either straight after treatment or a little while later.
Some people had active symptom control as usual. And some had FOLFOX chemotherapy as well as active symptom control.
A total of 162 people joined this trial. They were put into a treatment group at random:
- 81 had active symptom control (ASC)
- 81 had active symptom control and FOLFOX chemotherapy
The research team looked at how many people were living 12 months after joining the trial. They found it was:
- just over 1 out of 10 people (11%) who had ASC
- more than 2 out of 10 people (26%) who had ASC and FOLFOX
Many people who took part had at least 1 side effect from treatment. Some were mild or didn’t last long.
A few more people who had FOLFOX had more severe side effects. Three people who had FOLFOX died because of side effects of treatment.
The most common side effects were:
- a drop in white blood cells
- extreme tiredness (fatigue)
The trial team concluded that FOLFOX is a useful treatment for people with advanced biliary tract cancer.
They suggest this combination should be standard treatment for people whose cancer has come back after chemotherapy. They now have information on the pros and cons of FOLFOX, so patients can discuss whether they would like this treatment or not.
More detailed information
There is more information about this research in the reference below.
Please note, this article is not in plain English. It has been written for health care professionals and researchers.
Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial
Lamarca A and others
The Lancet Oncology, 2021. Volume 22, Issue 5, Pages 690 – 701.
Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists (
How to join a clinical trial
Professor Juan Valle
AMMF – The Cholangiocarcinoma Charity
Cancer Research UK
Conquer Cancer Foundation
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Stand Up To Cancer
The Cholangiocarcinoma Foundation
The Christie Charity
The Christie NHS Foundation Trust
This is Cancer Research UK trial number CRUK/13/004.